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AIM ImmunoTech Inc. (AIM)

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1.9350-0.0050 (-0.26%)
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  • T
    Tom
    The researchers who studied Ampligen at Johns Hopkins were quite surprised by the fact that Ampligen appeared to do almost nothing helpful in human subjects.

    "A surprising finding was the absence of detectable alpha or gamma interferon after administration of a drug that is an interferon inducer in vitro.

    ...In addition to the weak immunologic effect of poly(I):poly(C12U) at the doses used in the present study, the drug has some toxicity and is extremely awkward to prepare and administer.

    ...Our findings of low levels of immunologic modulation only in some subjects suggest that the poly(I):poly(C12U) dose that induces a consistent and measurable biologic response has yet to be identified."

    The authors of the study included Dr. T'so, one of the coinventors of Ampligen, who understandably gave up on Ampligen when it was shown to be useless in humans. But, Carter had fewer misgivings about promoting an ineffective product and went on to make many millions of dollars from selling shares of HEB to credulous investors.
  • L
    Luc
    With such news any other real biotech co. would be up strongly with big volume ...

    HEB / AIM isn't .... for a reason .... do your own dd !!
  • T
    Tom
    The FDA has serious concerns about the liver toxicity and increased risk for infection seen when Ampligen is given to humans.

    Here is what the FDA wrote:

    "Of the 13 Ampligen patients with abdominal pain, abnormal liver function tests were described in 7 patients (2 of whom were not classified as SAEs by the sponsor). One patient clearly fulfills the criteria for Hy’s Law for drug-induced liver injury (ALT ≥ 3x ULN and total bilirubin ≥ 2x ULN).20 This was a 43 year old male in Study AMP-516 who developed abdominal pain, chills, fever, nausea, vomiting, and myalgia following his first dose of 200 mg Ampligen. In the emergency room, the patient was found to be tachycardic with a fever of 103°F. In the provided medical records, laboratory findings included an AST of 1,048 IU/L (reference range 0-40), ALT 1,008 (reference range 0-40 IU/L), and total bilirubin 4.1 (reference range 0-1.3mg/dL). Symptoms reportedly resolved and the patient was restarted on Ampligen one week later at a dose of 20 mg, with was slowly increased over 6 months back to 200 mg. Of note, the results above were found in the original case report forms and supporting documents submitted by the investigator. In the sponsor’s narrative found in the body of the AMP-516 clinical study report, only the initial, much lower, LFT values were described, and this event was not reported as an SAE, which again calls into question the reliability of the safety data.

    Based on review of SAE narratives, there were 10 infections that occurred in the Ampligen treatment groups (4 in the AMP-502/AMP-516 trials and 6 in the open label trials). No SAEs related to infection occurred in the placebo group in AMP 502 and AMP 516. Four patients had respiratory events, and two were catheter-related sepsis (including one with Xanthomonas maltophilia). The others included recurrent urinary tract infection, abscess, and sinusitis."
  • B
    Beauford
    Tom is back to his history citations. Why doesnt he ever quote the EMA COMP panel that reviewed all the RECENT pancreatic cancer data and granted orphan designation. The transcript which is their words and not the company is available for all to see for themselves. Good luck with that history.
  • T
    Tom
    "Philadelphia, PA - December 1, 2009 - Hemispherx Biopharma, Inc. (NYSE Amex: HEB) (the "Company" or "Hemispherx"), announced that it received a Complete Response Letter from the US Food and Drug Administration ("FDA") which describes specific additional recommendations related to the Ampligen(R) NDA. In accordance with its 2008 "Complete Response" procedure, the FDA reviewers determined that they cannot approve the application in its present form and provided specific recommendations to address the outstanding issues.

    ...Most notably, the FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen(R) and recommends at least one additional clinical study which shows a convincing effect and confirms safety in the target population. The FDA indicated that the additional study should be of sufficient size and sufficient duration (6 months) and include appropriate monitoring to rule out the generation of autoimmune disease. In addition, patients in the study should be on more than one dose regimen, including at least 300 patients on dose regimens intended for marketing."

    And to date, there still remains no credible evidence of efficacy for Ampligen. HEB/AIM never did the study that the FDA told them would be necessary. They have managed to raise hundreds of millions of dollars over the years selling shares to credulous investors. However, they always seem to opt for frittering away the money they raise on executive compensation rather than doing the study that the FDA told them would need to be done.
  • T
    Tom
    Judge Yohn's opinion in the shareholder lawsuit Frater v. Hemispherx is worth reading for any investor in HEB/AIM.

    "In November 2009,3 after a period of review, the FDA sent Hemispherx a CRL explaining it would not be approving Ampligen. On December 1, 2009, Hemispherx issued a press release purporting to represent the explanation the FDA had given for denying the application. According to that press release, the CRL communicated the FDA determined “the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen and recommend[ed] at least one additional clinical study which shows a convincing effect and confirms safety in the target population.”
    Despite Hemispherx's awareness (1) of methodological problems with AMP 502 and AMP 516, (2) the FDA's determination that AMP 502 and AMP 516 did not produce credible evidence of Ampligen's efficacy, and (3) the FDA's specific recommendation in the CRL to pursue an additional clinical study, Hemispherx focused its post-CRL attention on reanalyzing the AMP 502 and AMP 516 trial results. These efforts first turned on finding a “biomarker” for Chronic Fatigue Syndrome, so as to better facilitate determining whether AMP 502 and AMP 516 participants actually suffered from Chronic Fatigue Syndrome rather than an alternative source of a similar set of symptoms. As of January 2012, however, multiple attempts by Hemispherx to find a biomarker for CFS had failed, such that biomarker-based assessment of Ampligen's effect in AMP 502 and AMP 516 was not an option."
  • T
    Tom
    The FDA was clearly very concerned about the safety data that was submitted for Ampligen.

    Here is what the FDA wrote:

    "The FDA reviewed and categorized information from all SAE narratives from CFS studies. This review identified nine potential safety concerns associated with Ampligen use including thrombosis, major cardiac events, malignancy, unusual ocular diagnoses (acute macular neuroretinopathy), infusion reactions, abdominal pain/liver function test abnormalities, psychiatric events, infections, and autoimmune disease.

    One patientexposed to Ampligen met the criteria for Hy’s law, which is used during clinicaldevelopment to assess a drug’s potential of inducing severe liver injury.2
    .
    Additional adverse events for patients exposed to Ampligen included flu syndrome, headache, pain, dizziness, rhinitis, pharyngitis, chills, diarrhea, vasodilatation, back pain, fever, pruritus, abnormal thinking, dyspnea, anxiety, allergic reaction, and gastrointestinal disorders. According to the Applicant’s analysis, there were statistically significant higher frequencies of flu syndrome, chills, vasodilatation, and dyspnea in
    patients exposed to Ampligen compared to placebo in Study AMP-516.

    While there are numerous safety concerns with Ampligen, there seem to be many discrepancies in the submitted data, limited long-term exposure, and limited number of control patients. "
  • T
    Tom
    The shareholder meeting comes up this week and investors will have a chance to vote on whether they approve of AIM's executive compensation package. Equels' friends on the compensation committee have only glowing things to say about Equels.

    From last year's 10-K exhibits:

    "WHEREAS, the Compensation Committee deems Equels performance to be outstanding;

    WHEREAS, the Compensation Committee of the Board commissioned Steven Hall & Partners to provide compensation comparisons of CEOs for six pharmaceutical/biotechnology companies in comparable fields with comparable clinical development programs. The comparisons provided by the consultant revealed that Mr. Equels has been significantly under compensated in both annual cash (6 of 7) and non-cash long term compensation (7 of 7). Moreover, Mr. Equels ownership percentage ranks 7 of 7 (0.8% vs 3.8% median);

    WHEREAS, because of past financial circumstances of the Company which have been ameliorated, and despite his stellar performance, Equels has not had an increase in base salary for over four years;

    WHEREAS, under Equels leadership the Company now enjoys a robust and stable financial status and significant clinical progress;

    ...3. Compensation.

    (a) As compensation for the services to be performed hereunder, the Company shall pay to the Employee a combination of short term (cash) and long term (options) compensation. Short term compensation will consist of a base salary ($850,000) and a year-end target bonus of $350,000 based on performance goals established by the Compensation Committee. Long term compensation will be provided by 300,000 non-qualified yearly stock options with one year vesting on November 30, 2021, and each anniversary date thereafter for advancing the long term objectives of the Company established by the Board of Directors with long-term performance goal evaluation by the Compensation Committee. The Employee, additionally, is hereby granted 300,000 non-qualified stock options with one-year vesting upon signing this agreement."
  • T
    Tom
    Hmmm... Their poster on the safety study showed that 44% of patients had adverse effects. AIM considered most of them to be mild to moderate, but given their history of misrepresenting severe adverse events from AMP-502 and AMP-516 in their previous NDA to the FDA, I would want to see more specific details about the adverse effects seen.

    And, of course, this study says nothing about efficacy--not that it was intended to test efficacy. But, I am only pointing this out due to the unfortunate tendency of the boiler room pumpers to claim there is proof of efficacy in studies that do not show efficacy.
  • L
    Luc
    My vision for the future of this "company" : next years new RS , followed by a new big pump and dump study
    ( probably alzheimer) and new boiler room aliases to support the "science" ... just mho !
  • L
    Luc
    Pumping studies is the only business of this company ...

    nuff said
  • L
    Luc
    Lying to the FDA and delivering false data was a very bad idea imho ....

    the Agency knows who they are dealing with ...
  • B
    Beauford
    for all the "serious" safety concerns Tom continues to mention. why did UPMC list on clinicaltrials.gov a new phase 2 advanced ovarian cancer study and actually comment that based on the clean safety profile of the phase 1 they are moving to a phase 2?
    Home - ClinicalTrials.gov
    clinicaltrials.gov
  • T
    Tom
    The outside reviewers at the FDA's ADCOM meeting had trouble deciding whether the data that HEB/AIM submitted was intentionally deceptive, or merely shoddy.

    From the transcript:

    "DR. GUALTIERI: What I'm trying to understand is, is there anything here that is actually considered
    deceptive, or is it shoddy? And then how does that affect my understanding of the efficacy and safety?

    DR. MICHELE: The question is, is there anything here that would suggest deception or fraud. And that's
    a very difficult question. We don't like to go there with our applications, and we generally assume that what the sponsor is telling us is accurate.

    In this case, we struggled a lot with that because, as we reviewed the sponsor's data, we found multiple areas of discrepancies, multiple places where we said, well, this doesn't match what's over here, and the sponsor said they did it this way. But when we actually did the analysis ourselves, we found out they did it a different way.

    So every time we see something like that, it raises our eyebrows a little bit and makes us wonder what else is in the database that we're not seeing.

    So we leave that to your discretion to figure out if for you that raises your eyebrows as well and calls into question the data in the study. "
  • T
    Tom
    I've seen people try to argue otherwise, but I still think that it was a catastrophic mistake for HEB/AIM to submit misleading safety data for Ampligen.

    Here is what the FDA had to say on this subject:

    "The safety assessment of Ampligen revealed a number of discrepancies in the sponsor’s data. Key issues include some serious adverse events not counted by the sponsor, marked laboratory abnormalities that were not reported in the database, miscoding of adverse events and reasons for discontinuation, lack of adverse event definitions, and misleading or incomplete presentations of data.

    These discrepancies raise significant questions about data from all of the trials and whether or not the data are sufficient to determine the safety profile of Ampligen. "
  • T
    Tom
    Ampligen, a synthetic dsRNA, always flops in human studies, likely because it is metabolized too rapidly by RNAses in humans. It was actually purposely designed to be metabolized rapidly in the hope that this would decrease the adverse effects seen in earlier synthetic dsRNA's. Unfortunately it is metabolized too rapidly to do anything useful in humans either.

    This is why Ampligen can sometimes be been shown to do various things with in vitro and some mouse studies, but always flops in human studies. Recently it flopped in the cancer studies at Roswell Park.

    This is why no rational investor should ever have any reasonable expectation that anything profitable will ever come of these Ampligen pumps, whether for Anthrax, Zika, Ebola, cancer, COVID, HIV, hepatitis, CFS, or the other hundred maladies that have been the subject of prior Ampligen pumps. .
  • T
    Tom
    Short interest in AIM remains tiny, and it continues to decline.

    "Shares Outstanding 47.85M
    Float 47.28M
    % Held by Insiders 1.19%
    Shares Short (Sep 15, 2021) 920.55k
    Short Ratio (Sep 15, 2021) 2.96
    Short % of Float (Sep 15, 2021) 1.95%
    Short % of Shares Outstanding (Sep 15, 2021) 1.92%
    Shares Short (prior month Aug 13, 2021) 989.82k"
  • T
    Tom
    I thought that the voting at the shareholder meeting was interesting.

    On question 3:

    Advisory, non-binding, vote on approval of the compensation of the Company’s Named Executive Officers:
    For: 1,878,296
    Against: 9,396,851

    And the voting for the officers was closer than usual for most companies:

    Thomas K. Equels
    For: 6,730,478
    Withheld: 4,766,710

    William M. Mitchell
    For: 5,828,742
    Witheld: 5,668,446

    Stewart L. Appelrouth
    For: 5,977,593
    Withheld: 5,519,595

    [I wonder if Equels voted for himself but against the other two]
  • L
    Luc
    New pump pr and once again the pps tanks ...

    this BOD has zero credibility imho ...
  • L
    Luc
    Almost 30 years ago, in the nineties , this BOD stated they would announce the name of the big pharma partner they chose "among many candidates fighting to work with ampligen" , in the weeks / months that would follow ( BEURSTIPS / Vlaams beleggersblad) ...since then they never stopped lying and misleading !